BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 537045 · Received July 30, 2004

    Report

    Report Number
    1644487-2004-00634
    Event Type
    Injury
    Date Received
    July 30, 2004
    Date of Event
    January 1, 2002
    Report Date
    April 29, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE NCP SYSTEM WAS PROGRAMMED TO OFF APPROXIMATELY 2.5 YEARS AGO. THE NCP SYSTEM HAS NOT BEEN PROGRAMMED BACK TO ON OR EXPLANTED. IT IS UNK WHY THE NCP SYSTEM WAS PROGRAMMED TO OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 100 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other EXPIRE DATE 06/30/2000, DATE OF MFG 06/25/1998.| MODEL 300-20 BIPOLAR LEAD,| STERILIZATION LOT NO. 12172C.